Heparin-Induced Thrombocytopenia: Development and Validation of a Predictive Clinical (Score-TIH)
This study has been completed.
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborators:
Hyphen BioMed
CIC-EC de Saint-Etienne
Groupe d'étude sur l'Hémostase et la Thrombose
Association Française des centres régionaux de Pharmacovigilance
Laboratoires Organon
Sanofi
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00748839
First received: September 5, 2008
Last updated: November 22, 2012
Last verified: November 2012
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Purpose
Although Heparin-induced thrombocytopenia (HIT) is a rare complication of heparin treatment, it results in a high rate of morbidity and mortality, the cumulative rate of thrombosis recurrence, amputation and death approaching 52 % at one month if no specific treatment is initiated. It is therefore vital to diagnose HIT as early and as reliably as possible to permit appropriate management of this rare condition.
During the acute phase of HIT, clinicians and biologists can only suspect this complication with a greater or lesser degree of confidence. Clinical data are not sufficiently sensitive or specific to confirm or refute thr diagnosis of HIT.
| Condition |
|---|
|
Heparin-induced Thrombocytopenia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Heparin-Induced Thrombocytopenia : Development and Validation of a Predictive Clinical Score: a Prospective Multicenter Study Under the Auspices of the French Haemostasis and Thrombosis Study Group (GEHT)in Cooperation With the French Association of Regional PharmacoVigilance Center (AFCRPV) |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:
Primary Outcome Measures:
- the final diagnosis of HIT established by five independent experts in haemostasis and determined by thrombocytopenia and confirmation of HIT by immunological and/or functional tests [ Time Frame: inclusion and 40 days after the inclusion ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- pathogenic nature of anti HPF4 antibodies of IgM and IgA type [ Time Frame: inclusion ] [ Designated as safety issue: No ]
- new biological test detecting HIT [ Time Frame: inclusion ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
blood sample
| Enrollment: | 2700 |
| Study Start Date: | March 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Purpose : To create and validate a score predicting the diagnosis of HIT
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
community sample
Criteria
Inclusion Criteria:
-
all patients presenting, either during or immediately after treatment:
- thrombocytopenia and/or venous or arterial thrombosis
- for whom a request for biological assessment to check for HIT (anti-H-PF4 ELISA test) is to be addressed to the specialized haemostasis laboratory participating in the study
Exclusion Criteria:
- do not possess sufficient clinical data prior to performance of the biological test
- cannot assure follow-up of the patient until normalization of the platelet count
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748839
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748839
Locations
| France | |
| ETS de Franche Conté - Laboratoire d'Immuno Hématologie | |
| Besançon, France, 25020 | |
| CHU Cavale Blanche Laboratoire d'Hématologie | |
| Brest, France, 29609 | |
| Laboratoire d'hématologie - Hôpital Louis Pradel | |
| Bron, France, 69500 | |
| Hôpital Antoine Beclère - Laboratoire d'hématologie | |
| Clamart, France, 92141 | |
| Laboratoire d'hématologie - CHU de Clermont Ferrand | |
| Clermont Ferrand, France, 63003 | |
| HCC Colmar - laboratoire d'hématologie | |
| Colmar, France, 68024 | |
| Laboratoire d'Hématologie - CHU le Bocage | |
| Dijon, France, 21034 | |
| Laboratoire d'hémostase - CCML | |
| Le Plessis Robinson, France, 92350 | |
| Hôpital Cardiologique - Laboratoire d'Hémostase | |
| Lille, France, 59037 | |
| CHU La Timone - Laboratoire Hématologie | |
| Marseille, France, 13385 | |
| Hôpital SAINT ELOI - CHU de Montpellier - Laboratoire d'Hématologie | |
| Montpellier, France, 34295 | |
| Hématologie biologique - CHU Nancy | |
| Nancy, France, 54511 | |
| HOTEL DIEU - CHU Nantes - Laboratoire d'Hématologie | |
| Nantes, France, 44093 | |
| Hématologie Biologique - Hôpital Tenon, | |
| Paris, France, 75002 | |
| Hôpital Necker Enfants Malades -Laboratoire d'Hématologie | |
| Paris, France, 75015 | |
| Hôpital BICHAT - Service d'hématologie immunologie | |
| Paris, France, 75018 | |
| G.H. Pitié Salpétrière - Labo Hémostase Pavillon Laveran | |
| Paris, France, 75851 | |
| Hôpital Européen Georges Pompidou - Service Hématologie Biologique A | |
| Paris, France, 75908 | |
| Hôpital Cardiologique - CHU Bordeaux | |
| Pessac, France, 33604 | |
| Laboratoire central d'hématologie - Hôpital R. DEBRE | |
| Reims, France, 51092 | |
| CHU de ROUEN | |
| Rouen, France, 76031 | |
| Laboratoire d'hématologie | |
| Saint-Etienne, France, 42055 | |
| Service d'Urgence et de Réanimation | |
| Saint-Etienne, France, 42055 | |
| CHU Strasbourg Hautepierre Laboratoire d'Hématologie | |
| Strasbourg, France, 67098 | |
| CMC Foch Laboratoire d'hémostase | |
| Suresnes, France, 92151 | |
| Hopital Purpan - Laboratoire d'hématologie | |
| Toulouse, France, 31059 | |
| CHU Trousseau - CTH - Service d'Hématologie Hémostase | |
| Tours, France, 37044 | |
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Hyphen BioMed
CIC-EC de Saint-Etienne
Groupe d'étude sur l'Hémostase et la Thrombose
Association Française des centres régionaux de Pharmacovigilance
Laboratoires Organon
Sanofi
Investigators
| Principal Investigator: | Bernard TARDY, MD | CHU de Saint-Etienne |
More Information
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00748839 History of Changes |
| Other Study ID Numbers: | 0801016 |
| Study First Received: | September 5, 2008 |
| Last Updated: | November 22, 2012 |
| Health Authority: | France: Ministry of Health France: French Data Protection Authority |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
HIT Heparin-induced thrombocytopenia heparin treatment venous thrombosis |
arterial thrombosis predictive clinical score biological test anti-H-PF4 antibodies |
Additional relevant MeSH terms:
|
Thrombosis Thrombocytopenia Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Blood Platelet Disorders Hematologic Diseases |
Calcium heparin Heparin Anticoagulants Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 30, 2016